Modular program-based one-time assessment of new use of the anticoagulants dabigatran and warfarin among individuals with a pre-existing condition of atrial fibrillation and other various pre-existing conditions, including anemia, chronic obstructive pulmonary disease (COPD), diabetes, hypertension, chronic kidney failure, acute kidney failure, peptic ulcer disease, acute myocardial infarction (AMI), heart failure, peripheral vascular disease, hospitalized stroke, urinary catheter, hospitalized bleed, chronic liver disease, hypercholesterolemia, malignancy, coronary revascularization, cerebral revascularization, transient ischemic attack (TIA), cerebrovascular disease, urinary incontinence, hospitalized pneumonia, cardioversion, cardioablation, intravenous (IV) anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), selective serotonin reuptake inhibitors (SSRIs), thyroid replacement medications, insulin, metformin, sulfonylureas, other diabetes medications, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), anti-arrhythmic, anti-platelet medications, beta-blockers, calcium channel blockers, digoxin, loop diuretics, potassium-sparing diuretics, thiazides, amiodarone, dronedarone, estrogen replacement, H2 antagonists, nitrates, statins, fibrates, antifungal medications, verapamil. Members were required to have evidence of these pre-existing conditions in the six months prior to the new dabigatran/warfarin use. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of October 19, 2010 to December 31, 2014. Modular programs are adaptable standardized programs. Results were generated using the Cohort Identification and Descriptive Analysis (CIDA) tool; click here for more information. Queries were distributed in July 2015. This report includes data from 15 Data Partners.
If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to firstname.lastname@example.org.
The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.